EUROIMMUN Anti-Collagen type VII ELISA (IgG)
- Registration number
- DE0509678
- Model name
- Anti-Collagen type VII ELISA (IgG)
- Model identifier
- EA 1947-4801 G
- Registration date
- August 23, 2024
- Risk class
- Class B
- Product owner
- EUROIMMUN Medizinische Labordiagnostika AG
- Registrant / registration holder
- EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.
Epidermolysis bullosa aquisita (EBA). The ELISA test kit provides a semiquantitative or quantitative in vitro assay for the determination of human autoantibodies of the immunoglobulin class IgG against collagen type VII. The test kit contains microtiter strips each with 8 individual break-off reagent wells coated with collagen type VII. In the first reaction step, diluted patient samples are incubated in the wells. In the case of positive samples, the specific IgG antibodies (also IgA and IgM) will bind to the corresponding antigenic site. To detect the bound antibodies, a second incubation is carried out using an enzyme-labelled anti-human IgG (enzyme conjugate) catalysing a colour reaction.
- Product owner address
- Seekamp 31, 23560 Lübeck, Germany
- Registrant address
- 438A ALEXANDRA ROAD, #02-05/10, ALEXANDRA TECHNOPARK, Singapore 119967
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.